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FDA 510(k)

PANCOAT T4 COATED TUBE RADIOIMMUNOASSAY KIT

K-Number: K854324 · 1985-12-05

ApplicantPantex, Div. Bio-Analysis, Inc.
Decision Date1985-12-05
Product CodeCDX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PANCOAT T4 COATED TUBE RADIOIMMUNOASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Pantex, Div. Bio-Analysis, Inc.. It received FDA 510(k) clearance on 1985-12-05 under 510(k) number K854324. The device is classified under product code CDX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PANCOAT T4 COATED TUBE RADIOIMMUNOASSAY KIT?

PANCOAT T4 COATED TUBE RADIOIMMUNOASSAY KIT is a medical device that received FDA 510(k) clearance on 1985-12-05. The listed applicant is Pantex, Div. Bio-Analysis, Inc.. The 510(k) number is K854324.

When did PANCOAT T4 COATED TUBE RADIOIMMUNOASSAY KIT receive FDA 510(k) clearance?

PANCOAT T4 COATED TUBE RADIOIMMUNOASSAY KIT received FDA 510(k) clearance on 1985-12-05, under 510(k) number K854324.

Who is the listed applicant for PANCOAT T4 COATED TUBE RADIOIMMUNOASSAY KIT?

The FDA 510(k) record lists Pantex, Div. Bio-Analysis, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PANCOAT T4 COATED TUBE RADIOIMMUNOASSAY KIT?

The FDA product code for PANCOAT T4 COATED TUBE RADIOIMMUNOASSAY KIT is CDX.

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Other records listing Pantex, Div. Bio-Analysis, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K102841PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAYK942658NEOSCREEN ELISA TSHK914107PROLACTIN IRMA IMMUNOMAGK912804FSH IRMA IMMUNOMAGK911839NEONATAL BLOOD SPOT TEST 17-HYDROXPROG RADIO KITK911050LH IRMA IMMUNOMAG

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Related Devices (Code: CDX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K961490ELECSYS T4 ASSAYBoehringer Mannheim Corp.K954312ACTIVE THYROXINE RIADiagnostic Systems Laboratories, Inc.K943416DELFIA NEONATAL THYROXINE KITWallac OYK934384AXSYM(TM) TOTAL T4Abbott LaboratoriesK932980TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116Sigma Diagnostics, Inc.K933426STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNOBaxter Diagnostics, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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